QLB and Radical Cystectomy, Postoperative Pain

Not Applicable

Completed

• Conditions: Chronic Pain Post-Proceduraal; Nausea and Vomiting, Postoperative; Postoperative Pain
• Interventions: Procedure: QLB

• Registration Number: NCT03328988
• Lead Sponsor: Tampere University Hospital

Brief Summary

There are ca 1000 new cases of bladder cancer in Finland/year. The curative therapy for high risk bladder cancer is radical cystectomy. The golden standard is still an open surgery despite development of laparoscopic techniques. Epidural analgesia is considered as most effective for the treatment of postoperative pain. However, there is a need for other effective options, because epidural analgesia has some contraindications and risks for serious complications. Recently quadratus lumborum block has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. Contrary to the need of epidural catether a single shot QLB has reported to last up to 48 hours.

Inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.

44 patients aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Detailed Description

44 patients, uindergoing radical cystectomy, aging 18-85 will be recruited based on a power calculation. The 44 patients will be divided in 2 groups, the intervention group receiving a quadratus lumborum block (75mg ropivacaine) and the no intervention group receiving the current standard care of our hospital -an epidural.

The primary outcome measure is the acute postoperative need for rescue analgesics. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and longterm outcomes such as quality of life and persistent pain.

Study Timeline

• Study Start: 2017-04-27
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Primary Completion: 2020-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• patients with bladder cancer coming to the open radical cystectomy.

Exclusion Criteria

• age under 18y or over 85y,
• diabetes type 1 with complications,
• no co-operation or inadequate finnish language,
• persistent pain for other reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	QLB	Single shot bilateral QLB, ropivacaine 75 mg (20 mL) per side, placed under ultrasound control, at the end of surgery. 22 patients will be allocated in this group.

Primary Outcome Measures

Name	Time	Method
opiate consumption	24 hours	intravenous patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
pain score	7 days	numerical rating scale
persistent pain	12 months	paindetect McGill
mobilisation	72 hours after surgery	standing up and mobilizing
postoperative nausea and vomiting	72 hours	numerical rating scale and amount of vomites
functional query	12 months	assessment how pain in operation region limits daily functions
quality of life	12 months	SF 36

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland